The FDA has approved a new fixed-dose combination — emtricitabine/rilpivirine/tenofovir DF (FTC/RPV/TDF) — for use in treatment-naive HIV-infected patients.
The treatment, marketed as Complera, is a single pill that should be taken once daily. The pill is contraindicated with some anticonvulsants, antimycobacterials, and proton-pump inhibitors (see the FDA alert for a full list).
Approval for the combination was based, in part, on data from previous phase III studies for rilpivirine, which the FDA approved in May. In his HIV and ID Observations blog, Dr. Paul Sax writes that data comparing rilpivirine with efavirenz demonstrate a trade-off between safety/tolerability (favoring rilpivirine) and efficacy (favoring efavirenz), and he wonders whether "this efficacy difference [will] be reduced now that the single-pill treatment is available — a question now being tested in an open-label clinical trial."
ORIGINAL ARTICLE
The treatment, marketed as Complera, is a single pill that should be taken once daily. The pill is contraindicated with some anticonvulsants, antimycobacterials, and proton-pump inhibitors (see the FDA alert for a full list).
Approval for the combination was based, in part, on data from previous phase III studies for rilpivirine, which the FDA approved in May. In his HIV and ID Observations blog, Dr. Paul Sax writes that data comparing rilpivirine with efavirenz demonstrate a trade-off between safety/tolerability (favoring rilpivirine) and efficacy (favoring efavirenz), and he wonders whether "this efficacy difference [will] be reduced now that the single-pill treatment is available — a question now being tested in an open-label clinical trial."
ORIGINAL ARTICLE
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